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The Focused Ultrasound Myoma Outcome Study (FUMOS); a retrospective cohort study on long-term outcomes of MR-HIFU therapy

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Abstract

Objectives

Since 2004, uterine fibroids have been treated with MR-HIFU, but there are persevering doubts on long-term efficacy to date. In the Focused Ultrasound Myoma Outcome Study (FUMOS), we evaluated long-term outcomes after MR-HIFU therapy, primarily to assess the reintervention rate.

Methods

Data was retrospectively collected from 123 patients treated with MR-HIFU at our hospital from 2010 to 2017. Follow-up duration and baseline (MRI) characteristics were retrieved from medical records. Treatment failures, adverse events, and the nonperfused volume percentage (NPV%) were determined. Patients received a questionnaire about reinterventions, recovery time, satisfaction, and pregnancy outcomes. Restrictive treatment protocols were compared with unrestrictive (aiming for complete ablation) treatments. Subgroups were analyzed based on the achieved NPV < 50 or ≥ 50%.

Results

Treatment failures occurred in 12.1% and the number of adverse events was 13.7%. Implementation of an unrestrictive treatment protocol significantly (p = 0.006) increased the mean NPV% from 37.4% [24.3–53.0] to 57.4% [33.5–76.5]. At 63.5 ± 29.0 months follow-up, the overall reintervention rate was 33.3% (n = 87). All reinterventions were performed within 34 months follow-up, but within 21 months in the unrestrictive group. The reintervention rate significantly (p = 0.002) decreased from 48.8% in the restrictive group (n = 43; follow-up 87.5 ± 7.3 months) to 18.2% in the unrestrictive group (n = 44; follow-up 40.0 ± 22.1 months). The median recovery time was 2.0 [1.0–7.0] days. Treatment satisfaction rate was 72.4% and 4/11 women completed family planning after MR-HIFU.

Conclusions

The unrestrictive treatment protocol significantly increased the NPV%. Unrestrictive MR-HIFU treatments led to acceptable reintervention rates comparable to other reimbursed uterine-sparing treatments, and no reinterventions were reported beyond 21 months follow-up.

Key Points

• All reinterventions were performed within 34 months follow-up, but in the unrestrictive treatment protocol group, no reinterventions were reported beyond 21 months follow-up.

• The NPV% was negatively associated with the risk of reintervention; thus, operators should aim for complete ablation during MR-guided HIFU therapy of uterine fibroids.

• Unrestrictive treatments have led to acceptable reintervention rates after MR-guided HIFU therapy compared to other reimbursed uterine-sparing treatments.

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Abbreviations

CTCAE:

Common Terminology Criteria for Adverse Events

DISC:

Direct skin cooling

MREC:

Medical Research Ethics Committee Board

MR-HIFU:

Magnetic resonance image-guided high-intensity-focused ultrasound

MRI:

Magnetic resonance imaging

NPV:

Nonperfused volume

RFA:

Radiofrequency ablation

UAE:

Uterine artery embolization

UMCU:

University Medical Centre Utrecht

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Funding

No grant or financial support was used for this research project. No author had any financial interest in the subject matter discussed in the submitted manuscript. All the authors state that this study complies with the Declaration of Helsinki.

Author information

IV made substantial contribution to the design, interpretation of data, and writing of the manuscript. JP made substantial contribution to the study design and obtaining ethical approval. ML had a major contribution in the collection of data and analyzing of the data. RP made a substantial contribution to the interpretation of the data and the writing of the manuscript. IN was involved in the analysis and the interpretation of data and revised the manuscript. CM had substantial contribution to the design of the study and revised the manuscript. LB and AF revised the manuscript critically for important intellectual content. MFB was involved in the interpretation of data and revised the manuscript. MNGB was responsible for the design of the study, facilitated the collection of data and interpretation of the data, and revised the manuscript. All authors read and approved the final manuscript.

Correspondence to Inez M. Verpalen.

Ethics declarations

Guarantor

The scientific guarantor of this publication is M.F. Boomsma, M.D., Ph.D.

Conflict of interest

The authors declare that they have no conflict of interest.

Statistics and biometry

One of the authors has significant statistical expertise: I.M. Nijholt, Ph.D. No complex statistical methods were necessary for this paper.

Informed consent

Written informed consent was obtained from all subjects (patients) in this study.

Ethical approval

Institutional Review Board approval was obtained.

Study subjects or cohorts overlap

The short- and mid-term results of some study subjects have been previously reported in the following:

• Ikink ME, Nijenhuis RJ, Verkooijen HM et al (2014) Volumetric MR-guided high-intensity focused ultrasound versus uterine artery embolisation for treatment of symptomatic uterine fibroids: comparison of symptom improvement and reintervention rates. Eur Radiol 24:2649–2657. https://doi.org/10.1007/s00330-014-3295-6

• Ikink ME, Voogt MJ, Verkooijen HM et al (2013) Mid-term clinical efficacy of a volumetric magnetic resonance-guided high-intensity focused ultrasound technique for treatment of symptomatic uterine fibroids. Eur Radiol 23:3054–61. https://doi.org/10.1007/s00330-013-2915-x

• Voogt MJ, Trillaud H, Kim YS et al (2012) Volumetric feedback ablation of uterine fibroids using magnetic resonance-guided high intensity focused ultrasound therapy. Eur Radiol 22:411–417. https://doi.org/10.1007/s00330-011-2262-8

• Ikink ME, van Breugel JMM, Schubert G et al (2015) Volumetric MR-guided high-intensity focused ultrasound with direct skin cooling for the treatment of symptomatic uterine fibroids: proof-of-concept study. BioMed Research International 2015:1–10. https://doi.org/10.1155/2015/684250

Methodology

• Retrospective

• Case–control study

• Performed at one institution

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Verpalen, I.M., de Boer, J.P., Linstra, M. et al. The Focused Ultrasound Myoma Outcome Study (FUMOS); a retrospective cohort study on long-term outcomes of MR-HIFU therapy. Eur Radiol (2020). https://doi.org/10.1007/s00330-019-06641-7

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Keywords

  • Uterine fibroids
  • MR-guided interventional procedures
  • High-intensity-focused ultrasound ablation